Trial Outcomes & Findings for Over Active Bladder Instillation Study - Botox (NCT NCT00667095)
NCT ID: NCT00667095
Last Updated: 2014-07-11
Results Overview
The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.
TERMINATED
PHASE3
25 participants
Baseline, 1 month, 3 months
2014-07-11
Participant Flow
A total of 25 subjects were recruited from 10/21/2008 to 8/19/2010. Three of these were determined to be screen failures before randomization, and another one was withdrawn prior to randomization. Twenty one subjects were randomized: 11 to Botox/DMSO, and 10 to DMSO only.
Participant milestones
| Measure |
Botox and DMSO Instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Botox and DMSO Instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Over Active Bladder Instillation Study - Botox
Baseline characteristics by cohort
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
71 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Smoking Status
Never smoked
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Smoking Status
Past smoker
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Smoking Status
Current smoker
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
History of Hypertension
Hypertension
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
History of Hypertension
No hypertension
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
History of Urinary Tract Infections (UTIs)
Previous history of UTIs
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
History of Urinary Tract Infections (UTIs)
No previous UTIs
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of Vaginal Births
0 vaginal births
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of Vaginal Births
1-2 vaginal births
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Number of Vaginal Births
≥ 3 vaginal births
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Body Mass Index
|
26 kg/m^2
n=5 Participants
|
30 kg/m^2
n=7 Participants
|
27 kg/m^2
n=5 Participants
|
|
Post-Void Residual Urine
|
15 mL
n=5 Participants
|
29 mL
n=7 Participants
|
17 mL
n=5 Participants
|
|
Incontinent Episodes during 24 Hours
|
6 Episodes
n=5 Participants
|
3 Episodes
n=7 Participants
|
4 Episodes
n=5 Participants
|
|
Median 24 Hour Pad Weight
|
166 g
n=5 Participants
|
179 g
n=7 Participants
|
166 g
n=5 Participants
|
|
Median Number of Pads Per Day
|
4 pads
n=5 Participants
|
5 pads
n=7 Participants
|
5 pads
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Change in Incontinence Quality of Life (I-QoL) Score
Change from baseline to 1 month
|
9.6 units on a scale
Standard Deviation 13.3
|
-3.9 units on a scale
Standard Deviation 11.6
|
|
Change in Incontinence Quality of Life (I-QoL) Score
Change from baseline to 3 months (n=11, 9)
|
8.6 units on a scale
Standard Deviation 14.4
|
-4.0 units on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life.
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
Change from baseline to 1 month
|
-2.5 units on a scale
Standard Deviation 4.0
|
2.0 units on a scale
Standard Deviation 5.9
|
|
Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
Change from baseline to 3 months (n=11, 9)
|
-1.8 units on a scale
Standard Deviation 4.2
|
1.1 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
Change from baseline to 1 month
|
-2.4 units on a scale
Standard Deviation 5.8
|
-0.5 units on a scale
Standard Deviation 4.4
|
|
Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
Change from baseline to 3 months (n=11, 9)
|
-2.5 units on a scale
Standard Deviation 5.1
|
0.8 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life.
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Change in Urogenital Distress Inventory (UDI-6)
Change from baseline to 1 month
|
-1.9 units on a scale
Standard Deviation 3.7
|
-0.1 units on a scale
Standard Deviation 1.9
|
|
Change in Urogenital Distress Inventory (UDI-6)
Change from baseline to 3 months (n=11, 9)
|
-0.9 units on a scale
Standard Deviation 3.6
|
-0.4 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months
1 month
|
6 participants
|
4 participants
|
|
Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months
3 months (n=11, 9)
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 monthsPopulation: Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).
Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: "Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."
Outcome measures
| Measure |
Botox and DMSO Instillation
n=11 Participants
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 Participants
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months
1 month
|
4 participants
|
1 participants
|
|
Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months
3 months (n=11, 9)
|
5 participants
|
0 participants
|
Adverse Events
Botox and DMSO Instillation
DMSO Instillation
Serious adverse events
| Measure |
Botox and DMSO Instillation
n=11 participants at risk
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 participants at risk
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Nervous system disorders
Hospitalization for body jerking and termons due to oligodendroglioma.
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Hospitalization for joint pain due to infection
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Hospitalization for tibial ulcer
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Botox and DMSO Instillation
n=11 participants at risk
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
DMSO Instillation
n=10 participants at risk
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
27.3%
3/11 • Number of events 4
|
50.0%
5/10 • Number of events 6
|
|
Cardiac disorders
High Blood Pressue
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Had fall, unable to walk
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Bladder spasms after instillation
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Swollen ankles
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Nose Bleed
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Left Distal Radius Fracture from a Twist and Fall
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place